APPLICATION
ANDA078956
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2026-04-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET · ORAL
Approval history
2026-04-09Labeling · Supplement 40 · standardAP
2026-04-09Labeling · Supplement 41 · standardAP
2022-07-08Labeling · Supplement 32 · standardAP
2022-07-08Labeling · Supplement 33 · standardAP
2022-07-08Labeling · Supplement 31 · standardAP
2019-12-06Labeling · Supplement 21 · standardAP
2019-12-06Labeling · Supplement 26 · standardAP
2019-12-06Labeling · Supplement 29 · standardAP
2019-12-06Labeling · Supplement 23 · standardAP
2016-09-19Labeling · Supplement 20 · standardAP
2016-09-19Labeling · Supplement 19 · standardAP
2016-09-19Labeling · Supplement 17 · standardAP
2014-12-12Labeling · Supplement 15 · standardAP
2014-12-12Labeling · Supplement 11 · standardAP
2014-12-12Labeling · Supplement 16 · standardAP
2012-04-25Labeling · Supplement 9AP
2012-04-25Labeling · Supplement 8AP
2011-03-30Labeling · Supplement 5AP
2010-07-28Labeling · Supplement 4AP
2010-02-23Labeling · Supplement 2AP
2009-09-22Labeling · Supplement 1AP
2009-01-27OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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